Safety and Efficacy of Recombinant Human Platelet-Activat... | NCT00037687

Studies
Safety and Efficacy of Recombinant Human Platelet-Activating Factor Acetylhydrolase for the Treatment of Severe Sepsis

NCT00037687

Sponsor

ICOS Corporation

Status

Terminated

Last Update Posted

Jun 24, 2005Estimated

Enrollment

2,500

Phase

Phase 3

Conditions

Sepsis

Interventions

rPAF-AH

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
BB-IND 9538

Status Module

Record Verification Date

Jan 2003

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Apr 2001

Primary Completion Date

Not provided

Completion Date

Dec 2004

First Submitted Date

May 20, 2002

First Submission Date that Met QC Criteria

May 20, 2002

First Posted Date

May 21, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Name	Class
Suntory Pharmaceutical	INDUSTRY

Description Module

Brief Summary

The objective of this study is to demonstrate that rPAF-AH is safe and reduces 28 day all cause mortality in patients with severe sepsis.

Detailed Description

This study is a randomized, double-blind, placebo-controlled, multicenter study of rPAF-AH compared to placebo in patients with severe sepsis. Eligible patients from investigative sites located throughout the United States and other countries will be randomized to receive either rPAF-AH or placebo administered daily for five consecutive days by intravenous (IV) infusion. All patients will be evaluated for safety and efficacy endpoints over 28 days. A follow-up evaluation will occur approximately 6 months after Day 28 to assess functional status and quality of life.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500

Name	Type	Description	Arm Group Labels	Other Names
rPAF-AH	Drug

Eligibility Module

Eligibility Criteria

Inclusion criteria

Clinical diagnosis of severe sepsis
At least 18 years old
Patient or legally authorized representative able to provide informed consent

Exclusion criteria

Severe lung injury (acute respiratory distress syndrome)
Immunocompromised
Severe liver disease
Inflammation of the pancreas, organ rejection, or burns to more than 30% of body
Enrolled in another clinical trial
Already participated in this or other rPAF-AH study
There is not a commitment to aggressive treatment
Has a disease with life expectancy less than 6 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mary E. Lonien, M.S.		Bothell	Washington	98021	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	The Pafase Phase II ARDS Prevention Study Group. Recombinant platelet-activating factor acetylhydrolase (Pafase) decreases the incidence of acute respiriatory distress syndrome (ARDS) and 28 day all cause mortality (Abstract). Intensive Care Med (2000); 26: S321.

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes